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Artificial Pancreas System

Automated Insulin Delivery for Pregnancy

N/A
Waitlist Available
Led By Eyal Dassau, PhD
Research Sponsored by Sansum Diabetes Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at delivery and up to 48 hours afterwards
Awards & highlights

Study Summary

This study is evaluating whether an artificial pancreas may help pregnant women with type 1 diabetes.

Eligible Conditions
  • Pregnancy
  • Type 1 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of iaps use during pregnancy up to 40 weeks of use
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of iaps use during pregnancy up to 40 weeks of use for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time in Target Glucose Range
Secondary outcome measures
Adverse Device Effects (ADE)
Glucose < 54 mg/dL
Glucose < 63 mg/dL
+12 more
Other outcome measures
Closed-Loop Active Time
Fetal Outcomes: Large for Gestational Age
Fetal Outcomes: Neonatal Hypoglycemia
+8 more

Side effects data

From 2014 Phase 3 trial • 41 Patients • NCT02137382
2%
Constipation
2%
Diarrhea
2%
Abdominal pain lower
2%
decreased appetite
2%
Gastric pH decreased
2%
hypoglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Creon N
Creon®

Trial Design

1Treatment groups
Experimental Treatment
Group I: AID EvaluationExperimental Treatment1 Intervention
After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Automated Insulin Delivery
2020
N/A
~10

Find a Location

Who is running the clinical trial?

Sansum Diabetes Research InstituteLead Sponsor
38 Previous Clinical Trials
2,268 Total Patients Enrolled
Mayo ClinicOTHER
3,206 Previous Clinical Trials
3,767,073 Total Patients Enrolled
Harvard UniversityOTHER
229 Previous Clinical Trials
474,573 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to join this experiment?

"This trial is no longer recruiting new candidates, as per the information on clinicaltrials.gov; it was initially posted in July 2020 and last edited in November 2022. Nevertheless, there are 1340 other trials searching for subjects at present."

Answered by AI

Is this medical research endeavor accepting participants over forty years of age?

"This particular clinical trial is limited to individuals between the ages 18 and 45. However, there are 238 other studies geared towards minors and 958 trials focused on elderly patients."

Answered by AI

Are there any eligibility criteria for participation in this clinical trial?

"This trial calls for 21 individuals with diabetes or an autoimmune condition aged between 18 and 45. To be accepted, they must meet the following conditions: being of age at time of screening (18 to 45 years old), pregnant from 14th week up to 32nd week gestation, willing to switch/continue using Novolog or Humalog during closed-loop session treatment period, and not starting any new non-insulin glucose lowering agents within duration of study."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Sansum Diabetes Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Automated Insulin Delivery in Pregnant Patients With Type 1 Diabetes With Extension Into Outpatient at Home
2020. "Automated Insulin Delivery in Pregnant Patients With Type 1 Diabetes With Extension Into Outpatient at Home". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04492566.
~2 spots leftby Apr 2025
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